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A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04052932
Collaborator
(none)
594
Enrollment
1
Location
4
Arms
24
Actual Duration (Months)
24.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to placebo and Allopurinol in patients with gout

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR4640 dose1
  • Drug: SHR4640 dose2
  • Drug: Placebo oral tablet
  • Drug: Allopurinol 300 MG
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
594 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase3, Multicentre, Randomized, Double-Blind, Allopurinol and Placebo-Controlled Study to Evaluate the Efficacy and Safety of SHR4640 Monotherapy in Subjects With Gout
Actual Study Start Date :
Jul 16, 2019
Actual Primary Completion Date :
Jul 14, 2021
Actual Study Completion Date :
Jul 14, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks

Drug: Placebo oral tablet
tablets，QD
Experimental: SHR4640 dose1

SHR4640 dose1 once a day, orally, for 36 weeks

Drug: SHR4640 dose1
tablets，dose1，QD
Experimental: SHR4640 dose2

SHR4640 dose2 once a day, orally, for 36 weeks

Drug: SHR4640 dose2
tablets，dose2，QD
Active Comparator: Allopurinol

Allopurinol 300mg (milligram) once a day, Orally, for 36 week

Drug: Allopurinol 300 MG
tablets，300mg，QD

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects with a serum uric level≤360μmol/l. [Week 12]

    Proportion of subjects with a serum uric level≤360μmol/l.

Secondary Outcome Measures

  1. Proportion of subjects with a serum uric level≤360μmol/l [Week 36]

    Proportion of subjects with a serum uric level≤360μmol/l

  2. Percentage change from baseline in serum uric level [Up to 36 weeks]

    Percentage change from baseline in serum uric level

  3. Actual change from baseline in serum uric level [Up to 36 weeks]

    Actual change from baseline in serum uric level

  4. Proportion of subjects with a serum uric level≤360μmol/l [Up to 36 weeks]

    Proportion of subjects with a serum uric level≤360μmol/l

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening;

  2. 18 kg/m2 ≤Body mass index (BMI)≤ 35 kg/m2

Exclusion Criteria:

  1. Subject who is pregnant or breastfeeding;

  2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;

  3. Subject with a positive test for HLA-B*5801;

  4. Estimated glomerular filtration rate (MDRD formula) <60ml/min;

  5. HbA1c>8%;

  6. Subject with known hypersensitivity or allergy to SHR4640 and allopurinal, or any component of SHR4640;

  7. Subject with kidney stones or suspicion of kidney stones;

  8. Subject who has acute gout flares within 2 weeks before randomization;

  9. Subject with a history of malignancy within the previous 5 years;

  10. Subject with a history of active peptic ulcer within a year;

  11. Subject with a history of xanthine urine.

Contacts and Locations

Locations

Site City State Country Postal Code
1 RenJi Hospital Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200000

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Chunde Bao, Shanghai Jiaotong University, School of Medicine, Renji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04052932
Other Study ID Numbers:
  • SHR4640-301
First Posted:
Aug 12, 2019
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gout
Allopurinol

Study Results

No Results Posted as of Jun 13, 2022